By: Kacal, et al. (Senate Sponsor - Bettencourt) H.B. No. 21
(In the Senate - Received from the House April 23, 2015;
May 6, 2015, read first time and referred to Committee on Health
and Human Services; May 21, 2015, reported adversely, with
favorable Committee Substitute by the following vote: Yeas 6, Nays
0; May 21, 2015, sent to printer.)
Click here to see the committee vote
COMMITTEE SUBSTITUTE FOR H.B. No. 21 By: Schwertner
A BILL TO BE ENTITLED
AN ACT
relating to authorizing patients with certain terminal illnesses to
access certain investigational drugs, biological products, and
devices that are in clinical trials.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. (a) This Act shall be known as the Right To Try
Act.
(b) The legislature finds that:
(1) the process for the approval of investigational
drugs, biological products, and devices in the United States takes
many years;
(2) patients with a terminal illness do not have the
luxury of waiting until an investigational drug, biological
product, or device receives final approval from the United States
Food and Drug Administration;
(3) the standards of the United States Food and Drug
Administration for the use of investigational drugs, biological
products, and devices may deny the benefits of potentially
life-saving treatments to terminally ill patients;
(4) patients with a terminal illness have a
fundamental right to attempt to pursue the preservation of their
own lives by accessing available investigational drugs, biological
products, and devices;
(5) the use of available investigational drugs,
biological products, and devices is a decision that should be made
by the patient with a terminal illness in consultation with the
patient's physician to pursue the preservation of the patient's own
life and is not a decision to be made by the government; and
(6) the decision to use an investigational drug,
biological product, or device should be made with full awareness of
the potential risks, benefits, and consequences to the patient with
a terminal illness and the patient's family.
(c) It is the intent of the legislature to allow for
patients with a terminal illness to use potentially life-saving
investigational drugs, biological products, and devices.
SECTION 2. Subtitle C, Title 6, Health and Safety Code, is
amended by adding Chapter 489 to read as follows:
CHAPTER 489. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS
WITH TERMINAL ILLNESSES
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 489.001. DEFINITIONS. In this chapter:
(1) "Investigational drug, biological product, or
device" means a drug, biological product, or device that has
successfully completed phase one of a clinical trial but has not yet
been approved for general use by the United States Food and Drug
Administration and remains under investigation in the clinical
trial.
(2) "Terminal illness" means an advanced stage of a
disease with an unfavorable prognosis that, without
life-sustaining procedures, will soon result in death or a state of
permanent unconsciousness from which recovery is unlikely.
SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
PRODUCTS, AND DEVICES FOR PATIENTS WITH TERMINAL ILLNESSES
Sec. 489.051. PATIENT ELIGIBILITY. A patient is eligible
to access and use an investigational drug, biological product, or
device under this chapter if:
(1) the patient has a terminal illness, attested to by
the patient's treating physician; and
(2) the patient's physician:
(A) in consultation with the patient, has
considered all other treatment options currently approved by the
United States Food and Drug Administration and determined that
those treatment options are unavailable or unlikely to prolong the
patient's life; and
(B) has recommended or prescribed in writing that
the patient use a specific class of investigational drug,
biological product, or device.
Sec. 489.052. INFORMED CONSENT. (a) Before receiving an
investigational drug, biological product, or device, an eligible
patient must sign a written informed consent. If the patient is a
minor or lacks the mental capacity to provide informed consent, a
parent or legal guardian may provide informed consent on the
patient's behalf.
(b) The executive commissioner of the Health and Human
Services Commission by rule may adopt a form for the informed
consent under this section.
Sec. 489.053. PROVISION OF INVESTIGATIONAL DRUG,
BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER. (a) A manufacturer
of an investigational drug, biological product, or device may make
available the manufacturer's investigational drug, biological
product, or device to eligible patients in accordance with this
chapter if the patient provides to the manufacturer the informed
consent required under Section 489.052.
(b) This chapter does not require that a manufacturer make
available an investigational drug, biological product, or device to
an eligible patient.
(c) If a manufacturer makes available an investigational
drug, biological product, or device to an eligible patient under
this subchapter, the manufacturer must provide the investigational
drug, biological product, or device to the eligible patient without
receiving compensation.
Sec. 489.054. NO CAUSE OF ACTION CREATED. This chapter does
not create a private or state cause of action against a manufacturer
of an investigational drug, biological product, or device or
against any other person or entity involved in the care of an
eligible patient using the investigational drug, biological
product, or device for any harm done to the eligible patient
resulting from the investigational drug, biological product, or
device.
Sec. 489.055. STATE MAY NOT INTERFERE WITH ACCESS TO
INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. An official,
employee, or agent of this state may not block or attempt to block
an eligible patient's access to an investigational drug, biological
product, or device under this chapter.
SUBCHAPTER C. HEALTH INSURANCE
Sec. 489.101. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
TRIAL ENROLLEES. This chapter does not affect the coverage of
enrollees in clinical trials under Chapter 1379, Insurance Code.
SUBCHAPTER D. PHYSICIANS
Sec. 489.151. ACTION AGAINST PHYSICIAN'S LICENSE
PROHIBITED. Notwithstanding any other law, the Texas Medical Board
may not revoke, fail to renew, suspend, or take any action against a
physician's license under Subchapter B, Chapter 164, Occupations
Code, based solely on the physician's recommendations to an
eligible patient regarding access to or treatment with an
investigational drug, biological product, or device, provided that
the recommendations made to the patient meet the medical standard
of care.
SECTION 3. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2015.
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